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OpenTrials
Completed

NCT Number: NCT00530998

Minimally Invasive Surgery: Using Natural Orfices

This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:

* Subjects will complete a 7 day pain/temperature log after surgery * Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery * Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction

Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for transvaginal appendectomy:

  • Females between the ages of 18-75
  • Clinical diagnosis of appendicitis
  • Emergency room evaluation within 36 hours of the onset of pain
  • ASA Classification 1
  • Mentally competent to give informed consent
  • Scheduled to undergo a transvaginal NOTES appendectomy.

Exclusion criteria

for transvaginal appendectomy:

  • Pregnant women (need to have negative icon in ER)
  • Morbidly obese patients (BMI >35)
  • Patients who are taking immunosuppressive medications or are immunocompromised
  • Patients with evidence of an abdominal abscess or mass
  • Patients who present with a clinical diagnosis of sepsis or peritonitis
  • Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
  • Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  • Patients with diffuse peritonitis on clinical exam
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion criteria

for transvaginal cholecystectomy:

  • Females between the ages of 18 and 75
  • Diagnosis of gallstone disease which requires cholecystectomy
  • ASA class 1
  • Mentally competent to give informed consent
  • Scheduled to undergo a transvaginal NOTES cholecystectomy

Exclusion criteria

for transvaginal cholecystectomy:

  • Pregnant women
  • Morbidly obese patients (BMI > 35)
  • Patients who are taking immunosuppressive medications and/or immunocompromised
  • Patients with severe medical comorbidities will be excluded.
  • Patients with a presumed gallbladder polyps, mass or tumor
  • Patients with a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
  • Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
  • Patients with known common bile duct stones
  • Patients on blood thinners or aspirin or abnormal blood coagulation tests

Treatment and study plan

Transvaginal Appendectomy

Procedure

The appendix will be removed via an incision in the vagina.

Transvaginal Cholecystectomy

Procedure

The gallbladder will be removed via an incision in the vagina.

Primary outcomes

  1. To evaluate the safety and efficacy of transvaginal NOTES appendectomies and cholecystectomies (through data collection).

    Time frame: 1 year

Secondary outcomes

  1. To evaluate pain associated with the transvaginal approach (through data collection).

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy

Acronym: NOTES

Important dates

Study start
2007
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2007
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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